Track and trace for pharmaceuticals lets you to pinpoint any item’s current and past locations in your supply chain. It’s a powerful tool that no pharma company can do without, especially as regulations mandate track and trace capabilities and specific requirements for recording and sharing supply chain data.
We’ve been doing track and trace for pharmaceuticals for almost 20 years, longer than any other solution provider, and we thought it was a good time to revisit the fundamentals as part of our ongoing discussion about the pharma supply chain. Let’s take a look.
The benefits of track and trace for pharmaceuticals
When designed and implemented correctly, a track and trace system for pharmaceuticals does exactly what its name promises: It tracks a drug, a vaccine, a medical device — anything in any configuration — as it moves forward through the supply chain and traces backward to reveal where it has been in the supply chain, all the way back to the individual ingredients or components that combined to create it.
Tracking lets you keep tabs on every item in your supply chain. Its many benefits include optimizing operational efficiency and speed; protecting against theft and diversion; ensuring your products remain safe and environmentally stable; and preventing counterfeit, adulterated, or expired medications from entering the supply chain.
Traceability lets you follow the trail of anything in your supply chain. Its many benefits include quick and efficient product returns; fast, modern recall management capabilities; brand protection; and building consumer confidence.
Serialization for pharma track and trace
Track and trace for pharmaceuticals relies on a deliberate combination of technologies and processes. Its “building block” is serialization, which endows a product with a unique identity that allows it to be tracked and traced 24/7, authenticated at any time (e.g., prior to sale, at dispensing, upon return, or during a recall), and turned into what we call a digital asset with numerous benefits and applications.
Serialized products must be supported by other processes and data points, which are derived through track and trace. For the U.S. Drug Supply Chain Security Act (DSCSA), those additional data points are supplied via so-called “T3” data (transaction history, transaction statement, transaction information).
In Europe, those data points are aggregated into a master database, the European HUB (EU HUB), as well as country-specific databases called the National Medicines Verification System (NMVS). In Russia, it’s the National Track and Trace Digital System (Chestny ZNAK).
Are track and trace regulations as common as serialization requirements?
Not every country with serialization requirements has track and trace requirements; however, regulators in many countries are starting to pair track and trace with serialization to achieve their goals, which include combating counterfeit, stolen, or adulterated drugs.
For example, right now, the U.S. DSCSA details how manufacturers must start the track and trace process by producing T3 data for drugs at the lot level. Stakeholders at every node of the supply chain — from wholesalers to repackagers and dispensers — must receive an electronic copy of the T3 data. They must also produce and add to the T3 data if they sell the product.
When the DSCSA requirements are fully implemented in November 2023, recalled or returned drugs will be easily tracked back through the supply chain. This will be accomplished through a switch from lot-level to unit-level (i.e., serialized) track and trace.
A little more about the DSCSA
If you follow our blog, get our newsletters, or visit our website, you know we’ve stayed on top of the DSCSA since Day 1.
We’ve led an FDA-approved pilot for the Verification Router Service, tracked changes to deadlines, written white papers, and explored upcoming requirements in depth. We’ve also hosted four successful webinars this year, the “Plan for DSCSA Readiness” in March and our three-part DSCSA 2023 series in June.
So check back often or drop us line with your questions about the DSCSA. We are your one-stop-shop of information as we work our way toward the full serialization of the U.S. pharmaceutical supply chain.
What happens if I don’t implement track and trace?
More and more, companies that don’t implement track and trace for pharmaceuticals are taking a great risk. They can face heavy fines and/or imprisonment, lose drug licenses, and be excluded from lucrative markets.
The EU Falsified Medicines Directive (FMD), for example, is very clear: no data or wrong data means no sale. In the United States, wholesale distributors cannot buy products that are not serialized or traceable, and manufacturers and repackagers run the risk of forfeiting their licenses if they do not serialize their products and initiate T3. Dispensers face similar risks if they accept and sell products without serial numbers and T3 data.
For more information about what countries require for track and trace for pharmaceuticals, check out our Global Compliance page and download our “Worldwide Pharmaceutical Compliance Requirements” white paper. The regulatory landscape is constantly changing, so it’s the wise company that takes the time to keep up with requirements, changes, and deadlines.
Track and trace for pharmaceuticals is no longer an option. It is a requirement for companies that want to do business in the United States, Europe, Russia, Brazil … virtually every market in the world. Put simply, not having a modern track and trace system is not a risk worth taking.
As we said above, rfxcel has been doing pharmaceutical track and trace for almost 20 years. We were founded on the principle of making the pharma supply chain safer and protecting consumers.
Today, we offer the industry’s most powerful track and trace solution. And now, as part of Antares Vision Group, we feel confident in saying that we offer the world’s most comprehensive solution for end-to-end supply chain track and trace. From L1 to L5, we have the hardware and software solutions that deliver all the benefits of track and trace for pharmaceuticals — or any product category.